Intrauterine element

ABSTRACT

An intrauterine contraceptive device has a continuous loop as a part thereof which is closed by a membrane of thin, pliable material. By use of a double layer and by selection of a permeable material for the membrane, it serves also to support a capsule containing a biological agent and a substance for slowly releasing the agent into the uterus.

0 United States Patent 51 3,659,596

Robinson 51 May 2, 1972 54 INTRAUTERINE ELEMENT 3,425,411 2/1969 Robinson ..123/130 [7 2] Inventor: Ralph R. Robinson, PO. Box 668, Mid FOREIGN PATENTS 0 ppuc 'no s dlesboro, Ky, 40965 487,197 12/1929 Germany ..l28/129 [22] Filed: Nov. 6, 1969 [21 APPL No: 874,511 Primary Examiner-l.awrence Charles Attorney-Schmidt, Johnson, Hovey & Williams [52] U.S. Cl ..l28/l30, 128/160 [57] ABSTRACT [51] Int. Cl .A6lf 5/46, A61m 31/00 58 Field of Search ..12s 1 27-1 3 1, 294, dev'ce has 128/295 260 160 a part thereof which is closed by a membrane of thin, pliable material. By use of a double layer and by selection of a perme- [56] References Cited able material for the membrane, it serves also to support a capsule containing a biological agent and a substance for UNITED STATES PATENTS slowly releasing the agent into the uterus.

3,256,878 6/1966 Schwartz et a1 ..128/130 4 Claims, 4 Drawing Figures Patented May 2, 1972' 3,659,596

INVENTOR. Ralph R. Robinsan Fig.4. 7' BY,

INTRAUTERINE ELEMENT An important object of my present invention is to improve upon the intrauterine device disclosed in my US. Pat. No. 3,425,411 dated Feb. 4, 1969.

While the intrauterine device of my patent aforementioned has been fully successful for its intended purpose, there have been certain isolated instances of difficulty arising from careless and inexpert insertion of contraceptive devices. Extreme negligence occasionally results in the device being inserted with such extreme force and indirection as to pierce the abdominal wall. If the device happens to be of the closed loop type there is presented a possibility of intestinal blockage if the intestines happen to become entangled within the closed loop of such device lodged in the abdominal cavity. Accordingly, in the interest of abundant caution, the open loop type of intrauterine contraceptive device has an additional safety factor in that the danger of intestinal blockage is removed.

It is, therefore, another important object of the instant invention to eliminate all possibility of the potential danger above explained from the closed loop type of device disclosed in said patent without in any way adversely affecting its advantages or manner of operation.

Still another important object of my instant invention is to close the continuous loop of the device of my patent with a thin, pliable membrane in such manner as to permit flexing of the arches of the loop in the same manner as fully explained in said patent.

A further object of the present invention is to provide means for advantageously utilizing the membrane as a support for a biological agent to be gradually released into the uterus over prolonged periods of time.

In the drawing:

FIG. 1 is an elevational view of an intrauterine element made in accordance with one form of my present invention;

FIG. 2 is an enlarged cross-sectional view taken on line 2-2 of FIG. 1;

FIG. 3 is a view similar to FIG. 1 illustrating a modified form of my present invention; and

FIG. 4 is an enlarged cross-sectional view taken on line 4- 4 of FIG. 3.

Inasmuch as the device shown in FIGS. 1 and 2 of the drawing and the device 12 illustrated in FIGS. 3 and 4 of the drawing are identical with the intrauterine contraceptive device of my patent above identified, except only for the improvements about to be described, the nature and manner of as somewhat taut between the branches 34 and 36, such is not necessary if, in order to assure proper flexing action on the part of branches 34 and 36, it should be deemed advisable to rather loosely mount the membrane 42 within the loop 14. Moreover, the material from which the membrane 42 is made might well be somewhat stretchable so that it will not in any sense impede the desired flexing of the arches 34 and 36.

In any event, it is desirable to enclose the membrane 42 entirely within the confines of the loop 14 centrally thereof as best illustrated in FIG. 2, and one manner of associating the membrane 42 with the loop 14 is to provide the membrane 42 with a peripheral head 44 embedded within the arches 34 and 36 The loop 24 of the device 12 is also provided with a thin pliable membrane 46 closing the loop 24 in much the same manner and for the same purpose as the membrane 42 for the loop 14. In addition, however, the membrane 46 has been adapted to serve a secondary purpose, namely, that of supporting a composition of material 48 which includes a biological agent, such as a medicament or a contraceptive. The composition 48 also includes a substance such as a lipid for slowly releasing the biological agent into the uterus.

Capsules of such nature are in wide general use and are usually embedded within the tissues of the patient whereas in the modified form of my invention shown in FIGS. 3 and 4, the prolonged and gradual diffusion of the active ingredient is made possible without need for any such implantation.

The aforementioned conventional capsules are provided with shells made from a permeable material, one example thereof in the nature of a silicone gum, is available from Dow use and operation thereof need not be repeated herein, said patent being incorporated herein by reference for a full understanding of my present invention.

Device 10, made entirely of flexible material, includes an elongated loop 14 having convex, outermost surfaces adapted to complementally engage the walls of the uterus at its mouth. It is to be noted that the loop 14 has a transverse axis which spans the distance across the uterus inwardly of its mouth, and a longitudinal axis provided with a lower vertex 16 for engaging the walls of the uterus in said mouth as well as an upper vertex 18 within the uterus, spaced inwardly from the walls of the latter, precisely as illustrated and described in my patent aforementioned.

A pair of coil elements 20 and 22 extend laterally in op posite directions from the upper vertex 18 for engaging the walls of the uterus within the mouths of the fallopian tubes.

In the same manner the element 12 has an elongated loop 24 provided with vertexes 26 and 28 and coil elements 30 and 32.

Loop 14 is provided with a pair of opposed, concavo-convex arches 34 and 36, and the loop 24 has arches 38 and 40 of identical nature.

The loop 14 is closed by a membrane 42 of thin, pliable material, and because of such nature of the material from which the membrane 42 is made, it will not in any manner interfere with or adversely affect the flexing action of the arches 34 and 36 toward each other in response to muscular action as described in my patent. While the membrane 42 is illustrated Coming Corporation of Midland, Michigan under the trademark SILASTICA.

Accordingly, such material is employed in the membrane 46 for enclosing the composition 48 and one manner of accomplishing this result is to provide a pair of layers 50 and 52, fused together at the periphery of the mass of composition 48 to hold the latter centered between the vertexes 26 and 28 as well as the arches 38 and 40.

Here again, the membrane 46 may be held in place, completely surrounded by the branches 38 and 40 by peripheral beads 54 on the layers 50 and 52 embedded within the arches 38 and 40 at the innermost peripheral margin of the loop 24.

Having thus described the invention, what is claimed as new and desired to be secured by Letters Patent is:

1. An intrauterine device of flexible material comprising:

an elongated continuous loop having convex, outermost surfaces adapted to complementally engage the walls of the uterus at the mouth thereof,

said loop having a transverse axis spanning the distance across the uterus inwardly of said mouth, and a longitudinal axis provided with a lower vertex for engaging the walls of the uterus in said mouth and an upper vertex within the uterus spaced inwardly from the walls of the uterus;

a pair of elements extending laterally in opposite directions from said upper vertex for engaging the walls of the uterus within the mouths of the fallopian tubes;

a membrane closing said loop; and

a permeable capsule carried by the membrane and containing a biological agent,

the membrane being permeable,

the agent-containing portion of the capsule being a part of the membrane,

said membrane being a double layer of thin, pliable material, said agent being between said layers.

2. A device as claimed in claim 1 wherein said loop has a pair of opposed, concavo-convex arches, said membrane spanning the distance between and interconnecting said arches.

3. A device as claimed in claim 2 wherein said agent is centrally located between the arches and between said vertexes.

4. A device as claimed in claim 3 wherein said capsule contains a substance for slowly releasing said agent into the uterus. 

1. An intrauterine device of flexible material comprising: an elongated continuous loop having convex, outermost surfaces adapted to complementally engage the walls of the uterus at the mouth thereof, said loop having a transverse axis spanning the distance across the uterus inwardly of said mouth, and a longitudinal axis provided with a lower vertex for engaging the walls of the uterus in said mouth and an upper vertex within the uterus spaced inwardly from the walls of the uterus; a pair of elements extending laterally in opposite directions from said upper vertex for engaging the walls of the uterus within the mouths of the fallopian tubes; a membrane closing said loop; and a permeable capsule carried by the membrane and Containing a biological agent, the membrane being permeable, the agent-containing portion of the capsule being a part of the membrane, said membrane being a double layer of thin, pliable material, said agent being between said layers.
 2. A device as claimed in claim 1 wherein said loop has a pair of opposed, concavo-convex arches, said membrane spanning the distance between and interconnecting said arches.
 3. A device as claimed in claim 2 wherein said agent is centrally located between the arches and between said vertexes.
 4. A device as claimed in claim 3 wherein said capsule contains a substance for slowly releasing said agent into the uterus. 